503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy is built to serve hospitals, surgery centers, clinics, and licensed healthcare providers that require consistent, compliant, and scalable access to compounded pharmaceuticals without patient-specific prescriptions. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practice (cGMP) standards and is subject to routine FDA inspection. This places it in a fundamentally different category than traditional 503A pharmacies. The focus is not retail compounding or one-off prescriptions. The focus is controlled production, batch consistency, sterility assurance, and regulatory discipline. The facility specializes in sterile injectable and non-sterile compounded medications designed to address drug shortages, support procedural efficiency, and improve supply chain reliability for healthcare providers. All production is performed in ISO-classified cleanroom environments using validated processes, documented quality systems, and lot-level traceability. Each batch undergoes appropriate sterility, endotoxin, and potency testing based on risk level and formulation requirements. 503B Compounding Pharmacy prioritizes transparency and compliance over speed or marketing claims. Products are compounded using USP-grade ingredients sourced from vetted suppliers, with full documentation available for healthcare partners. Beyond production, the pharmacy supports client institutions with regulatory documentation, recall readiness, adverse event reporting protocols, and consistent supply planning. The company exists to solve real operational problems for healthcare organizations. Drug shortages, inconsistent manufacturers, and unreliable distributors create risk for patient care. A properly run 503B facility reduces that risk by acting as a compliant, predictable manufacturing partner rather than a reactive supplier.
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of current Good Manufacturing Practices (cGMP), ensuring that every preparation meets rigorous quality and safety protocols. Our primary focus is on providing bulk quantities of compounded drugs for office use by healthcare practitioners, enabling them to have essential medications readily available for their patients.
The operations at our Longwood location are distinct from traditional compounding pharmacies. We serve a critical role in the healthcare supply chain by producing large-scale batches of medications that are often in short supply or unavailable from conventional manufacturers. This includes a range of preparations such as sterile injectables, ophthalmic drops, and topical formulations. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can confidently utilize our services, knowing that our processes are subject to FDA oversight, which includes routine inspections and stringent quality control measures. This provides an additional layer of assurance regarding the sterility, potency, and purity of the medications they administer.
Our facility at 2160 W State Road 434 is equipped with state-of-the-art technology and staffed by a team of highly trained pharmacists and technicians. Every batch of medication is compounded in a controlled environment and undergoes extensive testing to verify its integrity. For healthcare professionals practicing at this location, partnering with our 503B Compounding Pharmacy means gaining access to a reliable source of high-quality compounded medications, thereby enhancing patient care and practice efficiency. We are committed to supporting the local medical community with dependable pharmaceutical compounding services.
To learn more about our office-use compounding services or to place an order, please contact us directly. You can reach 503B Compounding Pharmacy by phone at (407)993-1381 or visit our website at . Our team at 2160 W State Road 434, Longwood, FL 32779 is ready to assist you.
FAQ
1. What does it mean that this facility is a 503B outsourcing facility?
It means our compounding pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under Section 503B of the FD&C Act. We follow current Good Manufacturing Practices (cGMP) and are subject to federal oversight and routine inspections, which differentiates us from traditional 503A compounding pharmacies.
2. Can I, as an individual patient, pick up a prescription directly from your location?
No. 503B Compounding Pharmacy primarily prepares large-scale batches of medications for office use by healthcare practitioners. Individual patient prescriptions are typically handled by traditional compounding pharmacies. Our services are designed for healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to stock and administer medications within their practice.
3. What types of medications do you compound at your Longwood facility?
Our FDA-registered outsourcing facility at 2160 W State Road 434 specializes in compounding sterile preparations, such as injectables, IV bags, and ophthalmic solutions, as well as non-sterile medications. We focus on drugs that are on the FDA’s shortage list or are not commercially available for healthcare providers to use.
4. How does the quality control process work at your facility?
Every batch of medication compounded at 2160 W State Road 434, Longwood, FL 32779 is produced under cGMP standards. This involves rigorous environmental monitoring, validation of sterilization processes, and thorough testing for sterility, potency, and endotoxins before the product is released for distribution to ensure the highest quality and safety.
5. How can a healthcare provider at this location place an order?
Healthcare practitioners can place an order for office-use compounded medications by contacting our facility directly. Please call us at (407)993-1381 to speak with our team about your specific needs. You can also find more information on our website at .